510(k) K822337

KF-101-07 DIALYZER by Extracorporeal Medical Specialities, Inc. — Product Code KOC

K822337 is an FDA 510(k) premarket notification submitted by Extracorporeal Medical Specialities, Inc. for the device "KF-101-07 DIALYZER". The FDA issued a decision of Substantially Equivalent on February 16, 1983. The device falls under product code KOC (Accessories, Blood Circuit, Hemodialysis), a Class II device regulated under 21 CFR 876.5820. Extracorporeal Medical Specialities, Inc. has at least 10 other 510(k) clearances on record.